Phase 3
Completed N=488
A Study Of SU011248 Plus Paclitaxel Versus Bevacizumab Plus Paclitaxel In Patients With Advanced Breast Cancer
Source: ClinicalTrials.gov NCT00373256 ↗Enrolled (actual)
488
Serious AEs
36.5%
Results posted
Oct 2010
Primary outcomePrimary: Progression-Free Survival (PFS) — 7.4; 9.2 Months — p=0.9986
Summary
To compare treatment with SU011248 plus paclitaxel versus bevacizumab plus paclitaxel to determine which treatment works better against breast cancer
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-Free Survival (PFS) |
7.4; 9.2 | 0.9986 |
| SECONDARY Number of Participants With Objective Response |
78; 78 | — |
| SECONDARY Duration of Response (DR) |
6.3; 14.8 | — |
| SECONDARY Overall Survival (OS) |
17.6; NA | — |
| SECONDARY Percentage of Participants Surviving at 1 and 2 Years |
76.8; 83.7; 35.5; 61.0 | — |
| SECONDARY European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) |
— | — |
| SECONDARY EORTC QLQ Breast Cancer Module (BR23) |
— | — |
| SECONDARY Euro Quality of Life-5 Dimension (EQ-5D) |
— | — |
| SECONDARY EQ - Visual Analog Scale (EQ-VAS) |
— | — |
| SECONDARY Biomarkers |
— | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of advanced breast cancer.
- Measurable disease as per RECIST (Response Evaluation Criterion) in Solid Tumors or bone-only disease.
- ECOG (Eastern Cooperative Oncology Group) performance status 0 or 1.
Exclusion Criteria
- No prior treatment with cytotoxics in the advanced disease setting.
- HER2/neu positive disease unless trastuzumab was previously received or is contraindicated.
- Treatment with a taxane in the adjuvant setting unless disease free interval >12 months after end of treatment.
Data sourced from ClinicalTrials.gov (NCT00373256). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.